8 — Class II medical device recall Z-1720-2022
Ongoing recall by ICU Medical, Inc., reported 2022-09-21, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
| Recall number | Z-1720-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2022-08-01 |
| Classified | 2022-09-09 |
| Reported by FDA | 2022-09-21 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AT, BE, BH, CA, CO, DE, EE, ES, FR, GB, IE, IL, IT, JP, KW, LU, MY, PE, PL, SA, SE, SI, SK, TH, TR, VN |
| Quantity | 5,795,989 units |
| Lot numbers | 5641882, 5692378, 5735432, 5735675, 5736601, 5738474, 5745619, 5746371, 5754551, 5754702, 5755485, 5755711, 5755784, 5755788, 5756766, 5757061, 5757376, 5772087, 5772482, 5772627, 5772638, 5772640, 5772683, 5773798, 5777168, 5777801, 5778247, 5787700, 5788509, 5788745, 5789359, 5789411, 5789539, 5789780, 5789784, 5789950, 5789984, 5800993, 5809713, 5810377 and 1 more |
Product
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Reason for recall
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1720-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.